Efficacy and Safety of Botulinum Neurotoxin NT 201 in Poststroke Upper Limb Spasticity

摘要: OBJECTIVE To assess the impact of new botulinum neurotoxin type A preparation NT 201 (Xeomin; Merz Pharmaceuticals GmbH, Frankfurt, Germany) on muscle tone, functional disability, and caregiver burden in patients with poststroke upper limb spasticity a randomized, placebo-controlled, double-blind study. METHODS One hundred forty-eight an Ashworth Scale score 2 or higher for wrist finger flexors at least moderate disability their principal therapeutic target Disability Assessment were treated either (median, 320 U) placebo followed up to 20 weeks. Treatment muscles was mandatory. RESULTS significantly proportion responders (improvement > =1 point score), as observed comparison 4 weeks after treatment (odds ratio, 3.97; 95% confidence interval, 1.9-8.3; P < 0.001, intent treat). For all flexor groups, statistically significant odds ratios favor week (P = 0.009). Statistically results postinjection visits until 12 0.005), global assessment efficacy 0.001), some tasks Carer Burden 0.05). Similar numbers each group experienced 1 adverse event (NT 201, n 21; placebo, 20). Importantly, none developed neutralizing antibodies. CONCLUSIONS led improvements tone well tolerated spasticity.